Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P +2 more— 510(k) K243708

Clearance details

Device name as filed

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

Applicant

Scivita Medical Technology Co., Ltd.

Product code

Code FGB

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2024-12-02

Decision date

2025-03-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Suzhou, CN

• K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)2026-09-09
• K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
• K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)2026-08-14
• K253505 — Zamenix P2026-08-07
• K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)2026-07-20

• K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more2026-01-20
• K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) +2 more2025-03-19
• K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)2024-10-23
• K240192 — Single-use Extraction Baskets2024-10-15
• K231521 — Broncho Videoscope System2023-11-14

Death

6

Injury

552

Malfunction

3,922

Other

1

Total

4,481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →